Pharmaceutical Key Trends 2011 - Biosimilar Market Overview

Introduction

In 2009, the combined biosimilars market size for the US and five major European markets was $150m. With more than 30 branded biologics with sales of $51bn set to lose patent exclusivity between 2011 and 2015, Datamonitor forecasts that the global biosimilar market will grow from $243m in 2010 to $3.7bn in 2015.

Features and benefits

• Overview of the biosimilar market, with biosimilar definitions in the US, EU and Japan, plus historical and forecast biosimilar sales out to 2015.
• Insight into the key drivers and resistors to biosimilar uptake in the developed and emerging markets.
• Assesses key factors determining successful biosimilar market access, and examines the major biosimilar players and the strategies they implement.
• Analyses biosimilar uptake in the five main European markets and provides insight into the future opportunities for biosimilar players.

Highlights

Due to their complexity, cost, and development risks, biosimilar production and commercialization in developed markets is concentrated among only a handful of pharma companies, all of which are established generics players.

Despite the introduction of approval pathways in the US, EU, and Japan, the growing use of biologics, and the need for more cost-effective treatments, all of which help drive biosimilar uptake, there remain a large number of barriers to uptake.

There are relatively few factors which limit the growth of the biosimilar industry in the developing markets, although the introduction of biosimilar pathways will restrict market access to many domestic biosimilar players, while low purchasing power and a high proportion of out-of-pocket expenditure, coupled with brand loyalty, limit access.

Your key questions answered

• Evaluate the evolving regulatory environment in the US, EU and Japan, and how this impacts biosimilar market access and uptake.
• Gain insight into the deal types among branded, generic and biosimilars players to either enter or bolster their position in the biosimilars market.
• Identify which branded biologics are facing patent expiry and provide significant opportunities for biosimilar developers.